Alembic Pharmaceuticals announces USFDA Tentative Approval for Dabigatran Etexilate Capsules, 150 mg

Alembic Pharmaceuticals Limited (Alembic) today announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Dabigatran Etexilate Capsules, 150 mg. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) PRADAXA® Dabigatran Etexilate Mesylate Capsules, Eq to 150 mg base, Boehringer lngelheim. Dabigatran Etexilate Capsules are indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, and for the treatment of deep venous thrombosis (DVT)' and pulmonary embolism (PE) in patients who have been treated with a parenteral anticoagulant for 5 to 10 days. It is also indicated to reduce the risk of recurrence of DVT and· PE in patients who have been previously treated.

Dabigatran Etexilate Capsules, 150 mg have an estimated market size of US$ 410 million for twelve months ending Sep. 2021 according to IQVIA.

Alembic has received year to date (YTD) 14 approvals (11 final approvals and 3 tentative approvals) and a cumulative total of 153 ANDA approvals (134 final approvals and 19 tentative approvals) from USFDA, including this first inhalational ANDA approval.

Shares of Alembic Pharmaceuticals Limited was last trading in BSE at Rs. 735.65 as compared to the previous close of Rs. 762.90. The total number of shares traded during the day was 67022 in over 3542 trades.

The stock hit an intraday high of Rs. 760.00 and intraday low of 724.40. The net turnover during the day was Rs. 49359826.00.

Source : Equity Bulls

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AlembicPharmaceuticalsLimited INE901L01018 533573 Pharmaceuticals ANDA USFDA TentativeApproval DabigatranEtexilateCapsules